The invention relates generally to an apparatus and method for collecting and transferring biological fluids. More particularly, the present invention relates to an apparatus and method for collecting and transferring a urine specimen in conjunction with a collection tube.
Biological fluids are collected periodically for laboratory analysis. Laboratory equipment that performs the analysis may only accept biological fluids stored in a test tube. However, a test tube is too small for the convenient collection of many biological fluids, such as urine. As a result, specimens often are collected in a fairly large container with a widely open top. After collection of the fluid in the container, the container is delivered to a medical technician. The technician then transfers a portion of the fluid to a test tube that can be sealed and transported to a laboratory for analysis. The transfer of biological fluid from the collection container to the test tube is an unpleasant task that creates the risk of contaminating the specimen or exposing the medical technician to potentially harmful pathogens in the specimen.
Some biological fluids such as blood are collected with assemblies that include a vacuum tube and a double-ended needle cannula. One end of the needle cannula is placed in communication with the biological fluid. The opposite end of the needle cannula is urged through a vacuum seal into the vacuum tube. Low pressure within the vacuum tube generates a flow of the bodily fluid through the needle cannula and into the tube. Such vacuum tubes are very convenient and efficient for collecting blood samples. However, for urine specimen collection, vacuum tubes are not very useful because vacuum tubes only have a limited shelf life due to a gradual migration of gas molecules through the walls of the tube. Additionally, sharps or pointed cannula require careful shielding to avoid potential skin punctures.
In urine collection, some prior art collection containers have a test tube that is attached. In these prior art devices, a portion of the urine specimen in the container is automatically transferred to the test tube. The test tube then may be separated from the container, sealed and shipped to a laboratory for analysis. However, these prior art assemblies can lead to leakage during the initial collection of the specimen or after the separation of the test tube from the collection container. Additionally, control of the volume of the specimen in the test tube may vary from sample to sample. A means for controlling the volume in each specimen sample taken is needed to assure accurate results in the subsequent laboratory analysis. Also, the use of a non-sharp or blunt fittings in the transfer of the specimen from the collection container to the test tube is preferred to avoid potential skin puncturing of the medical technician. Finally, a collection container designed to avoid contact with the user to prevent contamination of the specimen is desired. Prior art assemblies of collection containers can come into contact with the user""s hands during collection which contaminate the specimen in the collection container. Finally, there is a need for a collection container to use a non-evacuated vacuum tube to avoid the potential limited shelf life of the vacuum tube.
The present invention alleviates in great part the drawbacks associated with prior art fluid collection devices. Provided is a device for precise and controllable transfer of a specimen from a collection container to a test tube. The present invention preserves non-contamination during collection and transfer between the collection container and the test tube.
The invention is directed to a medical device for fluid collection with a test tube. The medical device has a container having a curved bottom, an open top defining a plane, and a plurality of side walls extending from the bottom to the top. The bottom has a top surface and a bottom surface. The top surface is sloped with respect to the plane. The top surface also has a hole located at the highest gravitational point relative to the plane.
The device further includes an open port protruding outwardly from the bottom surface. The open port is in fluid communication with the hole. The port has an attachment portion for releasably locking the test tube onto the port and enabling the test tube filling only when the container is tilted.
The medical device further comprises a support platform attached to at least one of the side walls for flat surface support. The platform is vertically attached to at least one of the side walls. Also, a horizontal support platform is centrally attached to the vertical support platform and at least one of the side walls.
In addition, the medical device further comprises a finger pad horizontally mounted onto the side walls adjacent to the hole and opposite the vertical and horizontal support platforms. The finger pad has a curved portion vertically and distally mounted to the finger pad for slip resistant holding.
The container and open port are made of a single unitary structure. However, they do not have to be so constructed and may be separate components.
The side walls further include a depression located adjacent to the open port for releasably locking the test tube during collection. The attachment portion of the open port is an interior luer fitting. The open port further includes a segmented annular sheath protruding from the bottom. One of the side walls further defines a recessed receptacle detail distal from the open port. The sheath and the receptacle detail are for providing additional releasable locking support to the test tube.
The side walls further define a depression adjacent to the hole on the top surface of the device. The depression is to mate with a connector which releasably locks the test tube during collection. The side walls further include a flat adjacent to the open port for supporting the flip lid during collection. The test tube further includes a closed bottom, a top and cylindrical side walls extending from the closed bottom to the top. A cap is disposed on the top of the test tube. The cap has a male luer fitting protruding distally from the cap. The open port that protrudes out from the bottom surface of the device has an interior luer fitting for releasably locking with the male fitting of the cap. This fitting enables the test tube to fill only when the container is tilted. Thus, even though the test tube is attached to the container, transfer of the fluid into the test tube does not automatically commence. The container must be tilted for transfer of the fluid to begin.
The cap further includes a hinge and a flip lid hingedly connected to the cap. The flip lid includes the connector that releasably locks into the depression to secure the test tube during collection. The open port further includes a segmented annular sheath. One of the side walls defines a recessed receptacle detail. The annular sheath protrudes from the bottom surface creating a space such that the hinge of the cap releasably locks into the space and the flip lid releasably locks into the receptacle detail.
The method for filling multiple test tubes used in the medical device comprises the steps of providing the container having a curved bottom, an open top, and a plurality of side walls, the bottom having a sloped top surface and a bottom surface. The top surface defining a hole located at the highest gravitational point on the top surface. The container further including an open port protruding out from the bottom surface and in fluid communication with the hole. A finger pad is mounted horizontally on the side walls adjacent to the hole and opposite a vertical and horizontal support platform. The support platforms are attached to the side walls for flat surface support. The next step is attaching the test tube to the open port. After the attachment step, the fluid is collected in the container. Contamination of the fluid is prevented by holding the finger pad. Next, the container is held by the vertical support platform, then, the container is tilted toward the hole to fill the test tube through the open port. The test tube is removed by placing the horizontal support platform of the container on a flat surface and pulling the test tube out of the open port. Finally, the test tube on the open port is replaced with another test tube and the container is tilted by the vertical platform toward the hole to fill the other test tube. In this method, the step of attaching the test tube to the open port is accomplished by an attachment portion, a segmented annular sheath, a depression and a recessed receptacle detail all included on the container.